Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,029 FDA device recalls in 2016.

Date	Product	Reason	Class	Firm
Dec 21, 2016	IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP...	Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 21, 2016	Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc...	AutoDELFIA System with Version 3.0 Software: Potential plate loading failures	Class III	PerkinElmer Health Sciences, Inc.
Dec 21, 2016	Agfa Healthcare NX 3.0.8950 Imaging Processing Software	A customer reported that when using an NX workstation with software version NX 3.0.8950 software ...	Class II	AGFA Healthcare Corp.
Dec 21, 2016	AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1...	Beckman Coulter initiated a design change to update the Automate PC image to accommodate the oper...	Class III	Beckman Coulter Inc.
Dec 21, 2016	Fresenius 2008T Series Hemodialysis System	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Dec 21, 2016	Fresenius 2008K2 Series : Hemodialysis System	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Dec 21, 2016	Monaco RTP System Product Usage: Used to make treatment plans for patient...	Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.	Class II	Elekta, Inc.
Dec 21, 2016	Fresenius 2008K@home Series : Hemodialysis System	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Dec 21, 2016	IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3P...	Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific ...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 20, 2016	VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. ...	There is a potential for biased results to be generated over the 10 day on-analyzer storage limit...	Class II	Ortho-Clinical Diagnostics
Dec 20, 2016	Eclipse Hypodermic Needle	BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaint...	Class II	Becton Dickinson & Company
Dec 20, 2016	Accu-Chek Connect Diabetes Management App	iOS and Android: Under certain conditions the affected app versions may disregard historical bolu...	Class II	Roche Diabetes Care, Inc.
Dec 20, 2016	Comprehensive Reverse Shoulder System Humeral Tray Model 115340	Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fractu...	Class I	Zimmer Biomet, Inc.
Dec 19, 2016	The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluorosco...	GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit...	Class II	GE OEC Medical Systems, Inc
Dec 19, 2016	UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465,...	Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne...	Class II	Beckman Coulter Inc.
Dec 19, 2016	OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile ...	GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit...	Class II	GE OEC Medical Systems, Inc
Dec 19, 2016	Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX...	Product complaints indicated that the part and lot numbers on the packaging differed from the phy...	Class II	Zimmer Biomet, Inc.
Dec 19, 2016	MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S...	Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-...	Class II	Bard Access Systems
Dec 19, 2016	NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System...	Dimensional non-conformity of the thread on the screw head.	Class II	In2Bones, SAS
Dec 19, 2016	OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide ...	GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit...	Class II	GE OEC Medical Systems, Inc
Dec 19, 2016	RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3m...	Product complaints indicated that the part and lot numbers on the packaging differed from the phy...	Class II	Zimmer Biomet, Inc.
Dec 19, 2016	NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois...	Dimensional non-conformity of the thread on the screw head.	Class II	In2Bones, SAS
Dec 19, 2016	SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin ...	Dimensional non-conformity of the thread on the screw head.	Class II	In2Bones, SAS
Dec 19, 2016	SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Pa...	Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-...	Class II	Bard Access Systems
Dec 19, 2016	DxH 600 Coulter Cellular Analysis System, Catalog No. B23858	Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne...	Class II	Beckman Coulter Inc.
Dec 16, 2016	Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM me...	Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartr...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 16, 2016	MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy	An error can occur causing Delta corrections to be lost when one setup field is closed and anothe...	Class II	Mevion Medical Systems, Inc.
Dec 16, 2016	IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec...	Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 16, 2016	Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method ...	Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge l...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 16, 2016	Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo...	The product was not functioning as intended. The ventilation to the patient was not disrupted, b...	Class II	Parker Medical
Dec 16, 2016	Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version N...	A software error caused the window/level to become the same in one series regardless if the image...	Class II	DICOM GRID INC
Dec 16, 2016	Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellc...	Labeling error: The label indicates the product is latex free, but the headband component include...	Class II	Covidien LLC
Dec 16, 2016	APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in...	Customer complaints received for the presence of leaks	Class II	Baxter Healthcare Corporation
Dec 16, 2016	Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrai...	labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the ...	Class II	Zimmer Biomet, Inc.
Dec 15, 2016	ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(lo...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM ...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.01...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenic...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.00...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.01...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	TVC Imaging System model TVC-MC9 , for the near-infrared examination of coron...	Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some...	Class II	Infraredx, Inc.
Dec 15, 2016	Boston Scientific Imager II Angiographic Catheter, a pathway for delivering c...	A field report indicated some units within this lot were missing the bottom pouch seal. The comp...	Class II	Boston Scientific Corporation
Dec 15, 2016	ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.0...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM I...	Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to p...	Class II	Zimmer Biomet, Inc.
Dec 15, 2016	ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.00...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 14, 2016	10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:...	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi...	Class II	MEDLINE INDUSTRIES INC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.